BEUDAMED
    FDA Recall Terminated

    Edwards Lifesciences EMBOL-X Glide Protection System; Model Numbers: EXGF24D, EXGF24LLD, EXGF24MMD, EXGF24SSD, EXGF24XLD, EXGF24XSD, EXGFXS2D, EXGF24SS2D, EXGF24MM2D, EXGF24LL2D and EXGF24XL2D. The EMBOL-X access device is indicated for the perfusion of the ascending aorta during short-term (less than or equal to0 6 hours) cardiopulmonary bypass (CPB) surgery where procedures may require the hemostatic introduction and removal of compatible intravascular devices into the vascular system.

    Recall: Z-0091-2014 · Initiated September 16, 2013

    Recall

    Recall Number
    Z-0091-2014
    Event Number
    66305
    Firm
    Edwards Lifesciences, LLC
    FEI Number
    1713910
    Product Code
    DWF
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    September 16, 2013
    Posted
    October 31, 2013
    Terminated
    March 10, 2017
    Address
    12050 Lone Peak Pkwy, Draper, UT, 84020-9414

    Description

    Edwards Lifesciences EMBOL-X Glide Protection System; Model Numbers: EXGF24D, EXGF24LLD, EXGF24MMD, EXGF24SSD, EXGF24XLD, EXGF24XSD, EXGFXS2D, EXGF24SS2D, EXGF24MM2D, EXGF24LL2D and EXGF24XL2D. The EMBOL-X access device is indicated for the perfusion of the ascending aorta during short-term (less than or equal to0 6 hours) cardiopulmonary bypass (CPB) surgery where procedures may require the hemostatic introduction and removal of compatible intravascular devices into the vascular system.

    Reason

    Edwards Lifesciences is recalling certain lots of EMBOL-X Glide Protection System due to deformation of the cannula tip.

    Action

    The firm, Edwards Lifesciences, sent an "URGENT FIELD SAFETY NOTICE PRODUCT RECALL-ACTION REQUIRED" letter dated September 16, 2013 via Fed-Ex to its consignees/customers. Consignees were asked to review inventory for the cannulae and remove the cannulae from any kits received; quarantine affected material at site and return product to Edwards LIfesciences, Attn: Santosh Bhagat, 12050 Lone Peak Drive, Draper, UT 84020, Attention: RECALL, RGA #; call Edwards Customer Service at 800-424-3278 to obtain RGA# and replacement product (note: the filter is not affected and does not have to be returned with the cannulae); and complete and return the attached acknowledgment form via fax to Edwards Customer Service at 800-422-9329 within three days of receipt of this Field Safety Notice. If you have any questions, please call Edwards Customer Service at 800-424-3278 from the hours 6:00am - 4:30pm PST or contact your Edwards' sales representative concerning the recall.

    Distribution

    Worldwide distribution: US (nationwide) and country of: Canada.

    Quantity

    12,034